# K140662: Flex  Endoscopic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Design Standards Corp.
- Decided: Jun 11, 2014 after 89 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904578 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091869: Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears, Covidien Lp, Formerly Registered AS United States (2009) Summary page 1.
- K951589: Manual Surgical Insrument, United States Surgical, A Division of Tyco Healthc (1995) Summary page 1.
- K914752: Auto Suture (R) Articulating Endoscopic Scissors, United States Surgical, A Division of Tyco Healthc (1992) Summary page 1.
- K912332: Microsurge Laser Fiber Holder, Microsurge, Inc. (1991) Summary page 1.
- K933725: Endoscopic Needle Driver, United States Surgical, A Division of Tyco Healthc (1994) Summary page 1.

## Indications for use
The FlexTM Monopolar Maryland Dissector is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue. The FlexTM Monopolar Needle Knife is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue. The FlexTM Monopolar Spatula is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue. The FlexTM Needle Driver is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue. The FlexTM Fenestrated Grasper is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue. The FlexTM Monopolar Scissor is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting of tissue. The FlexTM Laser Fiber Holder is a single use endoscopic device with applications in endoscopic surgical procedures to house and introduce a laser fiber.

Source page: https://510kreport.com/device/K140662
Methodology: https://510kreport.com/methodology